Decision-Making Tool for Blood Thinners

(DDInteract Trial)

Recruiting at 2 trial locations

Overseen By Ainhoa Gomez Lumbreras, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: Oral anticoagulants

Disqualifiers: Non-English/Spanish speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

3691 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It focuses on helping you and your doctor make informed decisions about drug interactions with blood thinners.

What data supports the effectiveness of the treatment DDInteract?

Research shows that using computer-based decision support systems can improve the quality of treatment for patients on blood thinners, which suggests that similar tools like DDInteract might help in managing blood thinner therapy effectively. ^{1 2 3 4 5}

Is the blood thinner treatment generally safe for humans?

Research on apixaban, a similar blood thinner, shows it is generally safe but can cause bleeding, which is a common risk with these types of medications. Safety data from studies indicate that while bleeding is a concern, the risk varies based on individual health factors. ^{6 7 8 9 10}

How is the DDInteract tool different from other treatments for managing blood thinners?

DDInteract is unique because it is a tool designed to enhance shared decision-making between patients and doctors by integrating into electronic health records, helping manage drug interactions specifically between warfarin and NSAIDs. ^{2 4 11 12 13}

What is the purpose of this trial?

The purpose of this project is to implement and evaluate a shared-decision making (SDM) tool called DDInteract that was developed to support decision making for drug-drugs interactions while on oral anticoagulants. DDInteract will be implemented in clinics at the University of Utah, University of Colorado and University of Vanderbilt. DDInteract will be launched from within the electronic health record (EHR) retrieving patient-specific risk factors, will calculate the risk of harm, and will allow providers and patients to dynamically explore "what if" scenarios to optimize treatment and minimize risk. DDInteract will enable shared-decision making using individually-tailored information on the potential benefits and harms of drug interactions in anticoagulated patients.

Research Team

Daniel C Malone, PhD

Principal Investigator

College of Pharmacy. University of Utah

Eligibility Criteria

This trial is for adults over 21 who are prescribed oral anticoagulants like warfarin or apixaban and take more than one medication. It's not suitable for those who can't communicate in English or Spanish.

Inclusion Criteria

I am 21 years old or older.

I am taking a prescribed oral blood thinner.

Exclusion Criteria

I cannot speak English or Spanish.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline period to assess initial risk of gastrointestinal bleeding before DDInteract implementation

12 months

Implementation

Implementation of DDInteract tool in clinics to evaluate its effectiveness in mitigating drug interactions

18 months

Follow-up

Participants are monitored for safety and effectiveness after the implementation of DDInteract

6 months

Treatment Details

Interventions

• DDInteract

Trial Overview The study tests a shared-decision making tool, DDInteract, designed to manage drug interactions in patients taking blood thinners. It integrates with electronic health records to assess risks and help doctors and patients make informed decisions together.

Participant Groups

Group I: Exposure to DDInteract tool in anticoagulated patients Experimental Treatment 1 Intervention

This population will consist in outpatient clinics who treat oral anticoagulated patients where DDInteract has been implemented. This intervention is referred to as DDInteract tool exposure in anticoagulated patients. DDInteract may be accessed by clinicians to evaluate risk of harm from drug-drug interactions for patients on anticoagulants.

Group II: Standard of Care Active Control 1 Intervention

This population will consist in outpatient clinics who treat oral anticoagulated patients where DDInteract has not yet been implemented.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Findings from Research

A new decision aid (DA) tool for patients with atrial fibrillation (AF) has been developed to help them understand their specific risks for stroke and bleeding when considering oral anticoagulant (OAC) treatments, based on a comprehensive review of literature and patient feedback.

The tool integrates risk assessment modules and preference assessments to facilitate shared decision-making, aiming to empower patients to make informed choices about their treatment options, although further research is needed to test its effectiveness in real-world scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a shared decision-making tool to assist patients and clinicians with decisions on oral anticoagulant treatment for atrial fibrillation. Kaiser, K., Cheng, WY., Jensen, S., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Management of oral anticoagulation in a population of children with cardiac disease using a computerised system to support decision-making. [2013]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Complex antithrombotic therapy: determinants of patient preference and impact on medication adherence. [2020]

3. Italy pubmed.ncbi.nlm.nih.gov

Effect of computer-aided management on the quality of treatment in anticoagulated patients: a prospective, randomized, multicenter trial of APROAT (Automated PRogram for Oral Anticoagulant Treatment). [2004]

4. England pubmed.ncbi.nlm.nih.gov

Development of a shared decision-making tool to assist patients and clinicians with decisions on oral anticoagulant treatment for atrial fibrillation. [2018]

5. England pubmed.ncbi.nlm.nih.gov

A patient decision aid to support shared decision-making on anti-thrombotic treatment of patients with atrial fibrillation: randomised controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The role of apixaban for venous and arterial thromboembolic disease. [2014]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Data-mining-based detection of adverse drug events. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Ascertainment and validation of major bleeding events in a primary care database. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Apixaban: a novel oral inhibitor of factor Xa. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Major bleeding with antithrombotic agents: a 2012-2015 study using the French nationwide Health Insurance database linked to emergency department records within five areas - rationale and design of SACHA study. [2019]

11. Canada pubmed.ncbi.nlm.nih.gov

Shared Decision-Making for Drug-Drug Interactions: Formative Evaluation of an Anticoagulant Drug Interaction. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Clinical pre-test of a computerised antithrombotic risk assessment tool for stroke prevention in atrial fibrillation patients: giving consideration to NOACs. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

Aspirin for primary prevention: USPSTF recommendations for CVD and colorectal cancer. [2019]